Psoriasis Clinical Trial

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Summary

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria

Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
Pregnant or nursing (lactating) women
Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT01892436

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 93 Locations for this study

See Locations Near You

Novartis Investigative Site
Anniston Alabama, 36207, United States
Novartis Investigative Site
Mesa Arizona, 85202, United States
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Paradise Valley Arizona, 85253, United States
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Upland California, 91786, United States
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Tamarac Florida, 33321, United States
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Eagan Minnesota, 55121, United States
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Saint Louis Missouri, 63117, United States
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Lincoln Nebraska, 68516, United States
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Freehold New Jersey, 07728, United States
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Charlotte North Carolina, 28210, United States
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Oklahoma City Oklahoma, 73103, United States
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Duncansville Pennsylvania, 16635, United States
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Charleston South Carolina, 29460, United States
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Columbia South Carolina, 29204, United States
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Jackson Tennessee, 38305, United States
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Benbrook Texas, 76126, United States
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Dallas Texas, 75216, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77074, United States
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League City Texas, 77573, United States
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Mesquite Texas, 75150, United States
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Seattle Washington, 98122, United States
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Caba Buenos Aires, C1181, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Buenos Aires , C1417, Argentina
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Caba , C1419, Argentina
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Cordoba , X5016, Argentina
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Córdoba , X5000, Argentina
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Maroochydore Queensland, 4558, Australia
Novartis Investigative Site
Malvern East Victoria, 3145, Australia
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Genk , 3600, Belgium
Novartis Investigative Site
Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Porto Alegre Rio Grande Do Sul, 90610, Brazil
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Sao Paulo SP, 04023, Brazil
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Sao Paulo SP, 04266, Brazil
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Sevlievo Gabrovo, 5400, Bulgaria
Novartis Investigative Site
Pleven , 5800, Bulgaria
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Sofia , 1612, Bulgaria
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St. John's Newfoundland and Labrador, A1A 5, Canada
Novartis Investigative Site
St. John's Newfoundland and Labrador, A1C 5, Canada
Novartis Investigative Site
Newmarket Ontario, L3Y 3, Canada
Novartis Investigative Site
Waterloo Ontario, N2J 1, Canada
Novartis Investigative Site
Trois-Rivieres Quebec, G8Z 1, Canada
Novartis Investigative Site
Bruntal Czech Republic, 792 0, Czechia
Novartis Investigative Site
Uherske Hradiste Czech Republic, 686 0, Czechia
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Zlin Czech Republic, 760 0, Czechia
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Aachen , 52064, Germany
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Erlangen , 91054, Germany
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Erlangen , 91056, Germany
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Gommern , 39245, Germany
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Hamburg , 22415, Germany
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Hildesheim , 31134, Germany
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Koeln , 50937, Germany
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Leipzig , 04103, Germany
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Nürnberg , 90429, Germany
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Ratingen , 40878, Germany
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Zerbst , 39261, Germany
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Ashkelon , 78278, Israel
Novartis Investigative Site
Haifa , 33394, Israel
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Ramat Gan , 52656, Israel
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Tel Aviv , 64239, Israel
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Catania CT, 95100, Italy
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Prato PO, 59100, Italy
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Siena SI, 53100, Italy
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Verona VR, 37134, Italy
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Lipa City Batangas, 4217, Philippines
Novartis Investigative Site
Dasmarinas Cavite, 4114, Philippines
Novartis Investigative Site
Manila Metro Manila, 1003, Philippines
Novartis Investigative Site
Las Pinas , 1740, Philippines
Novartis Investigative Site
Manila , 1003, Philippines
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Manila , 1008, Philippines
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Quezon City , 1102, Philippines
Novartis Investigative Site
Quezon City , 1118, Philippines
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Bialystok , 15-35, Poland
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Warszawa , 02-34, Poland
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Ekaterinburg , 62002, Russian Federation
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Ekaterinburg , 62010, Russian Federation
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Kemerovo , 65002, Russian Federation
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Moscow , 11552, Russian Federation
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St Petersburg , 19006, Russian Federation
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Yaroslavl , 15000, Russian Federation
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Singapore , 11907, Singapore
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Singapore , 16960, Singapore
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Singapore , 52988, Singapore
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Lucenec , 984 0, Slovakia
Novartis Investigative Site
Khon Kaen THA, 40002, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Chiang Mai , 50200, Thailand
Novartis Investigative Site
Leytonstone London, E11 1, United Kingdom
Novartis Investigative Site
Cannock Staffordshire, WS11 , United Kingdom
Novartis Investigative Site
Bradford West Yorkshire, BD5 0, United Kingdom
Novartis Investigative Site
Glasgow , G31 2, United Kingdom
Novartis Investigative Site
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT01892436

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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